Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
Vision RT is recalling 56 AlignRT InBore systems because information identifying the lasers and their characteristics was omitted from the Instructions for Use.
Sheathing Technologies is recalling 12 units of Sheathes3D vaginal and rectal ultrasound probe covers because product defects may result in contamination during use, posing an infection risk.
Vortex Surgical is recalling 221 units of its 25ga Illuminated Flex-Tip Laser Probe because some products in the lot are not passing through a 25ga cannula smoothly.
Beaver-Visitec International is recalling 5 BVI Leos Laser and Endoscopy Systems because ferrites specified for the USB cable assembly were not installed as intended.
Ferndale Laboratories is recalling 24,589 units of Mastisol Liquid Adhesive because the butyrate tube cracks during actuation, rendering the product unusable.
Philips Ultrasound is recalling 1,721 EPIQ Ultrasound Systems used with the X5-1c transducer because the system may experience an unexpected automatic reboot, resulting in damage to the transducer.
Draeger is recalling 431 Vapor 2000 anesthetic vaporizers because a certain component was not delivered within specification and contained impurities. The action is Class I.
Draeger is recalling 188 Vapor 3000 anesthetic vaporizers because a certain component was not delivered within specification and contained impurities. The action is Class I.
Alcon Research is recalling 151 Custom Pak ophthalmic procedure packs because the packs may have incomplete seals affecting sterility. The FDA has classified the action as Class I.
Beckman Coulter is recalling 36,981 bicarbonate reagents because they may generate falsely high bicarbonate results due to interference with lactate dehydrogenase in the sample.
AGFA Healthcare is recalling 35 DR 800 X-ray systems because it is possible to exceed the maximum allowed air kerma rate of 88mGy/min for pulsed fluoroscopy exams.
Diasol is recalling 186,000 containers of liquid concentrate for bicarbonate dialysis, product 100225-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Diasol is recalling 4,400 gallons of liquid concentrate for bicarbonate dialysis, product 100230-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Diasol is recalling 74,400 gallons of liquid concentrate for bicarbonate dialysis, product 100325-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Zimmer is recalling 11 Affixus Antegrade Femoral Nails, model 815509300, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509360, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609380, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Diasol is recalling 7,200 gallons of liquid concentrate for bicarbonate dialysis, product 100125-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609440, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609340, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815609420, because an undersized distal shaft diameter could lead to implant fatigue fracture.
ICU Medical is recalling LifeShield Drug Library Management software because Concentration Limits can only be defined to one decimal place instead of three, which may result in over- or under-delivery.
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609400, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509440, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Medtronic Neuromodulation is recalling 7,667 Restore Clinician Programmer Application devices after a Device Reset message could not be cleared, in rare cases preventing therapy from resuming.
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